Current Trials

1704025451

1609277731; CLO6799

Further information regarding clinical research studies approved by the FDA can be found at ClinicalTrials.gov. For interest in being a healthy subject volunteer please visit Indiana Clinical and Translational Institute or call 317.278.2176.

Indiana University Health Methodist Hospital

IRB # –Study Title – NCT# PI/Dept Age/Condition Purpose

1508589568 – Understanding outcomes with the EMBLEM™ S-ICD in primary prevention patients with low ejection fraction (UNTOUCHED)
NCT02433379

Bhakta Cardiology

 

≥ 21 yrs
Ventricular fibrillation, ventricular tachycardia, low cardiac output

To assess the 18-month incidence of inappropriate shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of sudden cardiac death. The incidence of inappropriate S-ICD shocks will be compared to the incidence of inappropriate shocks observed in the MADIT RIT study.

1607573902 – A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the Relay PRO Thoracic Stent-Graft in Subjects with Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers
NCT02818972

Corvera
Surgery
≥ 18 yrs  Investigate the safety and effectiveness of the Relay PRO Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms and penetrating atherosclerotic ulcers of the descending thoracic aorta.

1704025451 – A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the Relay PRO Thoracic Stent-Graft in Subjects with Traumatic Injury of the Descending Thoracic Aorta
NCT03090230

Corvera
Surgery

≥ 18 yrs
Traumatic injury to DTA no more than 30 days prior to planned stent implantation

 

To investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with traumatic injury of the descending thoracic aorta (DTA)

1609390966 – Pulmonary Arterial Hypertension Uptravi (SelexiPag):tHe usErs dRug rEgistry

Duncan
Cardiology
   
TDE-HF-301 – Oral treprostinil in subjects with pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF)
NCT03037580
Duncan
Cardiology
18 yrs to 79 yrs A multicenter, randomized (1:1; oral treprostinil to placebo), double-blind, placebo-controlled study in subjects with World Health Organization (WHO) Group 2 pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF).
TDE-HF-302 – Study of oral treprostinil in subjects with pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF)
NCT03043651
Duncan
Cardiology
 
18 yrs to 79 yrs To evaluate the safety of continued therapy with oral treprostinil in subjects who have completed Study TDE-HF-301. This study will provide long-term, open-label data regarding the effect of continued long-term oral treprostinil therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF).
1403948759 – Clinical investigation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation (PRESERVE)
NCT01208415
Fajardo 
Surgery

≥ 18 yrs
Aorto-iliac aneurysms, illiac aneurysms

 

To study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms.

1105005473 – Evaluation of reactivity of mononuclear cells to collagen V in lung transpant patients

 

Geraci 
Medicine- pulmonary, critical care, sleep & occupational medicine
  To evaluate reactivity of mononuclear cells to collagen V in lung transpant patients.
1608839771 – A non-interventional registry study of systemic antifungal therapy in adult subjects with invasive mucormycosis or invasive aspergillosis caused by a non-fumigatus species Hage
Medicine- pulmonary, critical care, sleep & occupational medicine
   
1608845528 – Observational disease registry of patients treated with systemic mold-active triazoles Hage
Medicine- pulmonary, critical care, sleep & occupational medicine
≥ 18 yrs (<18 yrs with parent or legal guardian consent) To describe representative real-world patterns of
care for the management of invasive fungal infections (IFIs),
including invasive mold infection (IMI)—specifically, to examine real world patient characteristics and
treatment patterns, associated healthcare resource utilization, and
outcomes associated with use of mold-active triazoles (MATs) to
treat IFIs.

1410508609 – Donor smoke exposure and the relationship to primary graft dysfunction

 

Hage
Medicine- pulmonary, critical care, sleep & occupational medicine
 

 

1412113692 – Extracorporeal photopheresis for the management of progressive bronchiolitis obliterans syndrome in medicare-eligible recipients of lung allografts
NCT02181257

Hage
Medicine- pulmonary, critical care, sleep & occupational medicine
≥ 18 yrs
Bronchiolitis obliterans syndrome (BOS)

To determine if Extracorporeal Photopheresis (ECP) is effective in the treatment of progressive Bronchiolitis Obliterans Syndrome (BOS) in patients after lung transplantation.

       

1403636387 – OPsumit USers Registry
NCT02126943

 

 

Harvey Medicine- pulmonary, critical care, sleep & occupational medicine Pulmonary arterial hypertension

To characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.

1310454500 – Beraprost-314d added-on to Tyvaso® (BEAT)
NCT01908699

 

 

Harvey Medicine- pulmonary, critical care, sleep & occupational medicine 18 yrs to 80 yrs

Pulmonary arterial hypertension
To assess the efficacy and safety of BPS-314d-MR when added-on to inhaled treprostinil (Tyvaso®)in patients with pulmonary arterial hypertension.

1602009422 – Safety and efficacy of inhaled treprostinil in adult PH with ILD Including CPFE (INCREASE)
NCT02630316

 

Harvey Medicine- pulmonary, critical care, sleep & occupational medicine 18 yrs to 79 yrs
Pulmonary hypertension, interstitial lung disease, combined pulmonary fibrosis and emphysema

To evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE)

1602009433 – An open-label extension study of inhaled treprostinil in subjects with pulmonary hypertension due to parenchymal lung disease (INCREASE OL)
NCT02633293

 

Harvey Medicine- pulmonary, critical care, sleep & occupational medicine ≥ 18 yrs
Pulmonary hypertension, interstitial lung disease, combined pulmonary fibrosis and emphysema

To evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 266 patients who completed all required assessments in the RIN-PH-201 study at approximately 75 clinical trial centers.

1707334701 – Multicenter, retrospective chart review of first-time Opsumit (macitentan) users in the United States (OrPHeUS)
NCT03197688

Harvey 
Medicine- pulmonary, critical care, sleep & occupational medicine
Child, Adult, Senior

The study is being done to further characterize the safety profile for Opsumit, primarily potential serious hepatic risks. Any patient who was a first-time user of Opsumit from October 2013- December 31, 2016.

1408941961 – Prospective, multicenter, multidisciplinary, controlled clinical investigation evaluating the safety and efficacy of PerClot® Polysaccharide Hemostatic System
NCT02359994

House
Surgery
≥ 22 yrs
Blood loss, surgical
To evaluate the safety and efficacy of PerClot in achieving intraoperative hemostasis compared to a similar marketed hemostatic device.

1506963342 – Phase 3 safety and efficacy study of ART-123 in subjects with severe sepsis and coagulopathy
NCT01598831

Kapoor Medicine- pulmonary, critical care, sleep & occupational medicine ≥ 18 yrs
Severe sepsis, coagulopathy

To evaluate if ART-123 given to patients who have severe sepsis complicated by at least one organ dysfunction and coagulopathy can decrease mortality.

1411663529 – National biological sample and data repository for pulmonary arterial hypertension

 

Lahm
Medicine- pulmonary, critical care, sleep & occupational medicine
 

 

CORT125134-451 – Phase 2 study of the safety and efficacy of CORT125134 in the treatment of endogenous Cushings syndrome
NCT02804750

Mariash
Medicine, endocrinology
18 yrs to 75 yrs

The purpose of this multi-center study is to evaluate the safety and efficacy of CORT125134 for treatment of endogenous Cushing's syndrome.

1204008386 – Medtronic product surveillance registry base protocol
NCT01524276

Mariash
Medicine, endocrinology
Child, Adult, Senior

To provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment.

1509192628 – Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure (CONCERT-HF)
NCT02501811
Murphy
Cardiology
21 yrs to 79 yrs To assess feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells (MSCs) and c-kit+ cardiac stem cells (CSCs) both alone and in combination (Combo), compared to placebo (cell-free Plasmalyte-A medium) as well as each other, administered by transendocardial injection in subjects with ischemic cardiomyopathy.
1611169140 – Evaluate the safety and efficacy of 48-hour infusions of HNO (nitroxyl) donor in hospitalized patients with heart failure (STANDUP AHF)
NCT03016325
Pang
Medicine, cardiology
≥ 18 yrs To evaluate safety and efficacy of continuous 48-hour intravenous infusions of HNO donor in hospitalized patients with heart failure and impaired systolic function

1403942864; D513BC00001 – A multinational, randomized double-blind placebo-controlled trial to evaluate the effect of Ticagrelor 90 mg twice daily on the incidence of cardiovascular death, myocardial infarction or stroke in patients with type 2 diabetes mellitus
NCT01991795

Revtyak
Medicine, cardiology

50 yrs to 130 yrs

The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus

1010002276 – Protocol for the collection and transfer of cystic fibrosis lungs for research purposes

 

Roe
Medicine- pulmonary, critical care, sleep & occupational medicine
 

 

1209009610 – The PARTNER II trial: Placement of AoRTic TraNscathetER valves
NCT01314313

 

 

Sinha Cardiology Symptomatic severe aortic stenosis

To determine the safety and effectiveness of the Edwards SAPIEN XT and the Edwards SAPIEN 3 transcatheter heart valve and delivery systems, which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

1510320657 – Clinical study to assess the efficacy and safety of macitentan in patients with pulmonary hypertension after left ventricular assist device implantation (Soprano)
NCT02554903

Wang
Cardiology
≥ 50 yrs
Pulmonary hypertension
To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation

1605941156 – SynCardia 50cc temporary total artificial heart (TAH-t) as a bridge to transplant (BTT)
NCT02459054
 

 

 

Wang
Surgery
≥ 10 yrs
Heart failure, right-sided, cardiac failure, heart failure, left-sided

To evaluate whether the 50cc TAH-t can safely support, and provide probable benefit to, transplant-eligible pediatric patients (aged 10 - 18 years) and can safely and effectively support transplant-eligible adult patients (aged 19 - 75 years) at imminent risk of death from biventricular failure without experiencing permanent disabling, stroke-related deficits.

1504262012 – Momentum 3 Multi-Center Study of MagLev TEchnology in Patients Undergoing MCS Therapy with Heartmate 3
NCT02224755

Wang
Surgery

18 yrs to 100 yrs

The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.

1509924992 – International EXPAND heart pivotal trial (EXPANDHeart)
NCT02323321
Wang
Surgery
≥ 18 yrs To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart
1610689278 – Reevaluation of systemic early neuromuscular blockade (ROSE)
NCT02509078
Williams
Medicine- pulmonary, critical care, sleep & occupational medicine
≥ 18 yrs To evaluate whether giving a neuromuscular blocker (skeletal muscle relaxant) to a patient with acute respiratory distress syndrome will improve survival.

1411712195 – A prospective, single arm, multi-center clinical study in collaboration with the interagency registry for mechanically assisted circulatory support (INTERMACS®) to evaluate the thoracotomy implant technique of the HeartWare HVAD® System in patients with advanced heart failure. (HVAD Lateral)
NCT02268942

Wosniak
Surgery
≥ 19 yrs
Left-sided heart failure
To evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD® System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS®) protocol and database

1309182139 – A clinical trial to evaluate the HeartWare® Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)
NCT01966458





 

Wozniak Surgery

≥ 18 yrs
Chronic heart failure

To evaluate the stroke incidence in patients implanted with a HeartWare® HVAD who receive optimal blood pressure management. The study compares results of stroke incidence in a new cohort of subjects receiving optimal blood pressure management to a reference stroke incidence observed in the original IDE clinical trial (HW004) that did not specify optimal blood pressure management.

1011003773 – A clinical trial to evaluate the HeartWare® Ventricular Assist System (ENDURANCE)
NCT01166347


 

Wozniak Surgery

≥ 18 yrs
Chronic heart failure

To determine the safety and effectiveness of the HeartWare Ventricular Assist System in patients with chronic Stage D/NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation.

1212010179 – Post-approval study on patients who received a HeartWare HVAD® during IDE trials (PAS)
NCT01832610
 

Wozniak Surgery

≥ 18 yrs
Heart failure

Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation.

1302010599 – Novel lung trial: normothermic ex vivo lung perfusion (Evlp) as an assessment of extended/marginal donor lungs
NCT01365429
 

Wozniak Surgery

≥ 18 yrs
Lung transplant

Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques.